TALKING DIGITAL THERMOMETER

K962369 · Ultmost Industrial Corp. · FLL · Aug 20, 1996 · General Hospital

Device Facts

• Record ID: K962369
• Device Name: TALKING DIGITAL THERMOMETER
• Applicant: Ultmost Industrial Corp.
• Product Code: FLL · General Hospital
• Decision Date: Aug 20, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Talking Digital Thermometer is intended for the measurement of human body temperature.

Device Story

Device measures human body temperature via electronic sensor; provides visual digital display and verbal announcement of temperature readings. Used in home or clinical settings by patients or healthcare providers. Verbal output assists visually impaired users in obtaining temperature readings. Device operates on battery power; provides rapid, accurate temperature measurement comparable to standard digital thermometers.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and comparison to predicate devices.

Technological Characteristics

Electronic clinical thermometer; thermistor-based sensing; battery-powered; digital display with integrated voice synthesis module for verbal temperature announcement.

Indications for Use

Indicated for the measurement of human body temperature in patients of all ages.

Regulatory Classification

Identification

A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.

Special Controls

(1) Device is not a clinical thermometer with telethermographic functions; (2) Device is not a clinical thermometer with continuous temperature measurement functions; and (3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.

Predicate Devices

• Blazie Engineering, Inc.'s TempTalk (K935466)
• Becton Dickinson and Co.'s B-D Flexible Digital Thermometer (K902624)
• K-Jump Health Co., Ltd.'s K-Jump Digital Clinical Thermometer (K903590)

Submission Summary (Full Text)

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K962369

AUG 20 1996

# 510(k) SUMMARY FOR ULTMOST INDUSTRIAL CORP.'S TALKING DIGITAL THERMOMETER

Submitter's Name, Address, Telephone Number, And Contact Person

Ultmost Industrial Corp.
4F, No. 52, Ming Chuang Road
Hsintien, Tapei
Taiwan, R.O.C.

Contact: Howard M. Holstein or Stephen Fang
Hogan & Hartson, L.L.P. Ultmost Industrial Corp.
Phone: [phone] 886 2 917 99 01
Facsimile: [phone] 011 886 2 917 76 03

## Date Prepared

May 15, 1996

## Name of the Device

Talking Digital Thermometer

## Common or Usual Name

Digital Thermometer with Verbal Announcement

## Classification Name

Clinical Electronic Thermometer (21 C.F.R. § 880.2910)

## Product Code

FLL

## Predicate Devices

1. Blazie Engineering, Inc.'s TempTalk (K935466);
2. Becton Dickinson and Co.'s B-D Flexible Digital Thermometer (K902624); and
3. K-Jump Health Co., Ltd.'s K-Jump Digital Clinical Thermometer (K903590);